Onychomycosis: Assessing Treatment Success by Quantification of the Infection Progression

Onychomycosis is an infection of nails caused by various fungal organisms. Depending on the type of fungus, the clinical features of onychomycosis can vary but can be generalized as thickened, brittle, discolored (white/yellow) and/or distorted nails. Despite it not being a life-threatening condition, it is considered to be an important public health issue due to its high prevalence, estimated at 5.5% worldwide (Tamer & Yuksel, 2019). At the core of drug and treatment development lies the requirement for assessing the patients’ response to therapy and the corresponding infection progression. In this context, having the tools to quantify the infected nail portion in a consistent manner and consequently tracking treatment efficacy over time is of great importance.

SCARLETRED is a digital health company that provides a novel solution for the standardized documentation, assessment, quantification, and analysis of conditions ranging from dermatological indications to drug reactions to fungal conditions. Scarletred®Vision is the CE certified Class I Medical Device developed by SCARLETRED: it integrates a clinically validated mobile software core enabling high-quality imaging and documentation of visually perceptible skin color and texture alterations and provides tools enabling medical professionals to analyze and quantify these changes. The system is ICH-GCP, GDPR, and HIPAA compliant and is a certified ISO-13485 Quality Management System. It is used in a wide variety of settings, including drug development in clinical trials (preclinical to phase IV), routine clinical work, hospital care as well as remote monitoring of patients. Furthermore, it can be used for eligibility assessment, to monitor disease progression and to evaluate the effectiveness of the investigational product.

‍

How does Scarletred®Vision work?

Scarltered®Vision consists of the following components:

• Mobile App: generation of high-quality images in conformity with data protection regulations and patient anonymity
• Skin Patches: calibration of the captured images for color, lighting conditions, and size
• Online Platform: documentation, assessment, and quantification of patient data

‍

The imaging and analysis procedures consist of three steps:

1. Place the skin patch on the healthy skin next to the area of interest
2. Take an image using the Scarltered®Mobile App. The image is automatically uploaded to the Online Platform
3. The analysis can be performed on the Platform, which offers multiple tools to assist the expert

The configurable measurement and analysis tools allow doctors to select one or more area(s) of interest (AOI); in the present case, the AOI is the target nail (Video 1). After the selection of the outer boundary of the target nail, the infected nail portions within the defined boundaries can be selected using the grid analysis tool. This enables doctors to clearly define the infected nail thereby accurately monitoring disease progression and nail growth (Video 2). Once the AOI has been selected, the software produces the corresponding data which can directly be visualized on the platform using the analytical tools. The results include the total area of the entire nail as well as the percentage of the infected area relative to the total nail (Video 2). Given its user-friendliness and usability on the Mobile App, this function allows experts to use this tool to efficiently assess patients´ eligibility for participation in a study while also enabling the monitoring of infection progression.

Video 1: Imaging onychomycosis patient´s toe using the Scarletred®Mobile App and Skin Patch. 00:03 : The Scarletred®QR Code is scanned. The QR-code is individual, anonymous, and patient-specific >>00:06 : The Scarletred®Skin Patch is placed on the healthy skin area in close proximity to the nail of interest (the Skin Patch allows the software to calibrate for lighting conditions and size/distance) >>00:11 : The high-quality image is generated on the Scarltered®Vision Mobile App and automatically normalized. >>00:16 : Each image has a timestamp; the user who generated it is also documented.

‍

‍

Video 2: Using the app’s Grid Tool to quantify the toenail. 00:03 : After capturing the image, the outer boundary of the target nail (AOI) can be selected (green drawing) directly on the Mobile App. The zoom function enlarges the toe to facilitate a precise selection. >> 00:05 : The grid tool appears in the selected AOI: the infected nail can be seamlessly selected (yellow squares). >> 00:12 : The software then automatically provides the analytical results: Total surface area of the healthy nail (green) and of the infected nail (yellow), Percentage of infected & healthy sections.

‍

SCARLETRED Classification tool

Scarletred®Vision also offers an AI-powered classification tool purposed to automatically classify and quantify areas with different colors and/or textures with minimal input by the expert, resulting in a highly efficient and precise data analysis. The classification tool is available on the Scarletred®Online Platform and its purpose is to quantify areas with different colors and/or textures in an AI-assisted manner, leading to great time- and effort efficiency as well as precision in the resulting data. These two areas are, in the case of onychomycosis, the healthy and infected sections of the nail. However, they can be defined as per study/clinician requirements. Similarly to the aforementioned grid tool, the classification tool divides the nail into very small sections: the expert simply selects a few representative areas of the healthy and infected nail sections (Image X). Based on the color and texture of these areas, the AI then analyzes the entire nail and automatically detects all areas that it classifies as healthy and infected. The better the user input is, the better the AI can learn to differentiate between healthy and infected areas.

‍
Scarletred®Vision’s innovative approach to creating digital solutions is the first of its kind. Its modular framework makes it applicable to all skin conditions (dermatological diseases, injection sites, drug reactions, allergic reactions, cosmeceuticals and many more). The certified Medical Device offers digital documentation and analytical tools that have been proven, both in the clinical and home-based settings, to increase data quality, enable doctors to quantify visual parameters, to improve patient treatment regimen and patient compliance, save doctors time, and generate analyses that are not obtainable with other technologies in the field. 

Interested in finding out more? Don’t be a stranger!  Get in touch with our Team so that we can tailor our solution to best fit your needs:  support@scarletred.com‍